Time of onset of vardenafil orodispersible tablet in a real-life setting–looking beyond randomized clinical trials
Articolo
Data di Pubblicazione:
2017
Citazione:
Time of onset of vardenafil orodispersible tablet in a real-life setting–looking beyond randomized clinical trials / P. Capogrosso, E. Ventimiglia, L. Boeri, A. Serino, A. Russo, G. La Croce, U. Capitanio, F. Deho, F. Montorsi, A. Salonia. - In: EXPERT REVIEW OF CLINICAL PHARMACOLOGY. - ISSN 1751-2433. - 10:3(2017), pp. 339-344. [10.1080/17512433.2017.1288567]
Abstract:
Background: A rapid onset of action for phosphodiesterase type 5 inhibitors (PDE5is) emerged to be of clinical importance in men treated for erectile dysfunction (ED). Data from randomized clinical trials (RCTs) showed a rapid onset of action for vardenafil 10 mg orodispersible tablet (ODT). However, the effectiveness of vardenafil ODT has never been tested in a real-life setting. We assessed the efficacy and time to onset of action of vardenafil ODT in men seeking medical help for ED in the everyday real-life clinical practice. Research design and methods: Patients completed a baseline and follow-up International Index of Erectile Function (IIEF), along with a 8-item self-administered questionnaire about onset of action and overall treatment outcomes. Descriptive statistics tested efficacy rates, patient timing of drug intake and time to post-dosing onset of action. Results: Overall, 118(59.9%) patients used vardenafil ODT. Satisfactory erections for vaginal penetration were reported in 39(34.5%) and 26(21.8%), patients in =15 and =30, minutes post-dosing, respectively. Minimal Clinically Important Differences (MCIDs) criteria and Yang’s criteria for responders were obtained in 80(67.8%) and 72(60.8%) patients. Conclusions: This study showed that one in three patients had satisfactory erection for vaginal penetration in less than 15 min post-dosing in the real-life setting.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Erectile dysfunction; phophodiesterase type 5 inhibitors; time to onset; vardenafil; Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Surveys and Questionnaires; Tablets; Time Factors; Treatment Outcome; Vardenafil Dihydrochloride; Young Adult
Elenco autori:
P. Capogrosso, E. Ventimiglia, L. Boeri, A. Serino, A. Russo, G. La Croce, U. Capitanio, F. Deho, F. Montorsi, A. Salonia
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